Intravaginal Electrical Stimulation in Idiopathic Overactive Bladder

Bladder Training With and Without Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial

Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urge urinary incontinence (UUI), usually with frequency and nocturia, in the absence of urinary tract infection. Currently, a wide range of therapeutic options exist for the treatment of OAB. These include first-line conservative (physical) therapies which focus on electrical stimulation (ES) and behavioral therapies such as lifestyle modifications, bladder training (BT), pelvic floor muscle training with or without biofeedback, second-line therapies which are pharmacologic, and third-line therapies which either neuromodulate or chemodenervate the bladder.

In clinical practice, BT and Intravaginal ES (IVES) are frequently used together in the treatment of women with OAB, but the evidences/results of the combined (BT+IVES) use of these two treatment options are so rare that they can be neglected in the literature. There is only one study including BT+ES treatment arm (one of the four treatment arms) in women with idiopathic OAB in the literature. In a study, BT+ES was not found to be effective both from BT alone and from the untreated control group. While interpreting the results of this study, it should be take into consideration that patients treated received relatively few treatment sessions (nine treatment sessions, once weekly) in this study. In addition, in the light of authors clinical experience, the investigators think that this issue is still open for research. Moreover, there is no recommendation on conservative combinations in the guidelines due to insufficient data.

This study is the first prospective randomized controlled trial that compares the efficacy of BT and BT plus IVES in women with idiopathic OAB. In this study, the investigators aimed to evaluate the efficacy of BT with and without IVES on incontinence-related QoL and clinical parameters in women with idiopathic OAB.

Study Overview

• Status: Completed
• Conditions: Electrical Stimulation; Idiopathic Overactive Bladder; Bladder Training
• Intervention / Treatment: Other: Bladder Training; Other: Electrical stimulation (IVES)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • None Selected
    • Denizli, None Selected, Turkey, 20100
      • Hakan Alkan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women over the age of 18 with clinical diagnosis of idiopathic OAB
• Urodynamically diagnosed detrusor overactivity
• The strength of pelvic floor muscle 3/5 and more
• Able to give written, informed consent
• Able to understand the procedures, advantages and possible side effects
• Willing and able to complete the voiding diary and QoL questionnaire

Exclusion Criteria:

• History of conservative therapy (BT, ES) for OAB within 3 months
• Previously treated with antimuscarinics (within 4 weeks)
• Pregnancy or intention to become pregnant during the study
• Current vulvovaginitis or urinary tract infections or malignancy
• History of urogynecological surgery within 3 months
• Anatomic structural disorders of genital region that could not allow to apply the vaginal probe
• Having stage 2 or more according to the pelvic organ prolapse quantification
• Cardiac pacemaker or implanted defibrillator
• Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
• Ultrasonographic evidence of residual urine volume more than 100 ml
• Allergy to condom or lubricant gel that is used with perineometer/vaginal probe

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1: Bladder Training - Control group; Specific goals are to correct faulty habit patterns of frequent urination, improve control over bladder urgency, prolong voiding intervals, increase bladder capacity, reduce incontinence episodes and restore patient confidence in controlling bladder function	Other: Bladder Training; Bladder Training
Active Comparator: Group 2: Bladder Training+Intra Vaginal Electrical Stimulation; IVES was performed in lithotomy position via Enraf Nonius Myomed 632 device with a vaginal probe. IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24-session treatment program of ES. The stimulation parameters were frequency at 10 Hz, a 5-10s work-rest cycle and 100 ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 0-100 mA. The intensity was controlled according to patients' discomfort level feedback	Other: Bladder Training; Bladder Training; Other: Electrical stimulation (IVES); IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24 session treatment program of IVES.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incontinence episodes-incontinence related outcomes measures	Patients with a 50% or greater reduction in incontinence episodes were consider positive responders (number of voiding per day)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of voiding-incontinence related outcomes measures	it was used frequency from data with a bladder diary (number of voiding per day)	8 weeks
nocturia frequency- incontinence related outcomes measures	it was used nocturia from data with a bladder diary (number of voiding per night)	8 weeks
incontinence related quality of life questionnaire	(IIQ-7) (score)	8 weeks

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 19892010-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No